Methods of dynamic annuloplasty ring sizing

• US 9,788,949 B2
• Filed: 05/16/2016
• Issued: 10/17/2017
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US15/155,863
• Publication Number:
  US 20160256278A1
• Time in Patent Office: 519 Days
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 5/107 Measuring physical dimensions, e.g. size of the entire body or parts thereof
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods.

Claims

1. A method for sizing a heart valve annulus, comprising:

preparing a sizing device including a proximal handle having an actuator, a shaft coupled to and extending in a distal direction from the handle, a generally C-shaped annuloplasty ring replica having a first free end and a second free end and coupled to a distal end of the shaft configured to be adjusted to a plurality of different ring sizes, wherein the annuloplasty ring replica is elongated and defines a shape of the annulus being sized and is biased to a maximum ring size, wherein the shaft has a hollow bore, and wherein the sizing device further includes at least one flexible tension member coupled to the actuator in the handle that passes through the hollow bore that extends along the shaft and then through aligned channels in a plurality of articulating segments defining an arc of the annuloplasty ring replica, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to reduce the ring size of the annuloplasty ring replica to a plurality of different ring sizes smaller than the maximum ring size;

reducing the size of the adjustable ring replica to less than the maximum ring size using the actuator;

positioning the adjustable ring replica at or near a patient'"'"'s native mitral valve or tricuspid valve annulus;

increasing the ring size of the adjustable ring replica using the actuator until an outer surface contacts the valve annulus; and

determining an appropriate ring size of prosthetic annuloplasty ring for the valve annulus.

2. The method according to claim 1, wherein the annuloplasty ring replica comprises a backbone segment coupled to the shaft including a first backbone end and a second backbone end opposite the first backbone end, wherein a first plurality of the articulating segments serially coupled to one another extend in an elongated manner from the first backbone end to the first free end of the annuloplasty ring replica, and wherein a second plurality of the articulating segments serially coupled to one another extend in an elongated manner from the second backbone end to the second free end of the annuloplasty ring replica.

3. The method according to claim 1, wherein the annuloplasty ring replica further includes a plurality of aligned extension wire channels in a plurality of articulating segments and a flexible extension wire extending therethrough that biases the annuloplasty ring replica to the maximum ring size, wherein tension on the flexible tension wire reduces the ring size of the annuloplasty ring replica against the bias of the flexible extension wire.

4. The method according to claim 1, wherein the shaft is malleable and couples to the annuloplasty ring replica with a swivel joint, and the step of positioning includes bending the handle and/or re-orienting the annuloplasty ring replica relative to the handle.

5. The method according to claim 1, further comprising a display on the handle configured to provide the ring size of annuloplasty ring that corresponds to incremental ring sizes of the annuloplasty ring replica, wherein the step of determining includes observing the display when the adjustable ring replica contacts the valve annulus.

6. The method according to claim 1, wherein a proportional shape of the annuloplasty ring replica also changes for different ring sizes.

7. The method according to claim 6, wherein the annuloplasty ring replica is more D-shaped for smaller ring sizes and more circular for larger ring sizes.

8. A method for sizing a heart valve annulus, comprising:

preparing a sizing device including a proximal handle having an actuator, a shaft coupled to and extending in a distal direction from the handle, a generally C-shaped annuloplasty ring replica having a first free end and a second free end and coupled to a distal end of the shaft configured to be adjusted to a plurality of different ring sizes, the annuloplasty ring replica comprising a plurality of articulating segments defining an arc of the annuloplasty ring replica and each segment being pivotable with respect to one or more respective adjacent articulating segment;

positioning the adjustable ring replica at or near a patient'"'"'s native mitral valve or tricuspid valve annulus;

adjusting the ring size of the adjustable ring replica using the actuator until an outer surface contacts the valve annulus; and

determining an appropriate ring size of prosthetic annuloplasty ring for the valve annulus.

9. The method according to claim 8, wherein the sizing device further includes at least one elongated member coupled to the actuator in the handle and extending along the shaft to the annuloplasty ring replica, the elongated member being configured, when actuated, to pivot the articulating segments so as to adjust the ring size of the annuloplasty ring replica to a plurality of different ring sizes.

10. The method according to claim 9, wherein the shaft has a hollow bore and the at least one elongated member comprises a flexible tension member that connects to the actuator, passes through the hollow bore, and extends through aligned tension wire channels in the plurality of articulating segments, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to adjust the ring size of the annuloplasty ring replica.

11. The method according to claim 10, wherein the annuloplasty ring replica comprises a backbone segment coupled to the shaft including a first backbone end and a second backbone end opposite the first backbone end, wherein a first plurality of the articulating segments serially coupled to one another extend in an elongated manner from the first backbone end to the first free end of the annuloplasty ring replica, and wherein a second plurality of the articulating segments serially coupled to one another extend in an elongated manner from the second backbone end to the second free end of the annuloplasty ring replica.

12. The method according to claim 10, wherein the annuloplasty ring replica further includes a plurality of aligned extension wire channels in a plurality of articulating segments and a flexible extension wire extending therethrough that biases the annuloplasty ring replica to a maximum ring size, wherein tension on the flexible tension wire reduces the ring size of the annuloplasty ring replica against the bias of the flexible extension wire.

13. The method according to claim 8, wherein the shaft is malleable and couples to the annuloplasty ring replica with a swivel joint, and the step of positioning includes bending the handle and/or re-orienting the annuloplasty ring replica relative to the handle.

14. The method according to claim 8, further comprising a display on the handle configured to provide the ring size of annuloplasty ring that corresponds to incremental ring sizes of the annuloplasty ring replica, wherein the step of determining includes observing the display when the adjustable ring replica contacts the valve annulus.

15. The method according to claim 8, wherein a proportional shape of the annuloplasty ring replica also changes for different ring sizes.

16. The method according to claim 15, wherein the annuloplasty ring replica is more D-shaped for smaller ring sizes and more circular for larger ring sizes.

17. The method according to claim 15, wherein the shaft has a hollow bore and a flexible tension member connects to the actuator, passes through the hollow bore, and extends through aligned channels in a plurality of articulating segments defining an arc of the annuloplasty ring replica, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to reduce the ring size of the annuloplasty ring replica, and wherein the channels in adjacent articulating segments are in different locations relative to a pivot point to cause the proportional shape of the annuloplasty ring replica change for different ring sizes.

18. A method for sizing a heart valve annulus, comprising:

preparing a sizing device including a proximal handle having an actuator, a shaft coupled to and extending in a distal direction from the handle, a generally C-shaped annuloplasty ring replica having a first free end and a second free end and coupled to a distal end of the shaft configured to be adjusted to a plurality of different ring sizes, wherein the annuloplasty ring replica is elongated and defines a shape of the annulus being sized and is biased to a maximum ring size, wherein a proportional shape of the annuloplasty ring replica also changes for different ring sizes, and wherein the shaft has a hollow bore and a flexible tension member connects to the actuator, passes through the hollow bore, and extends through aligned channels in a plurality of articulating segments defining an arc of the annuloplasty ring replica, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to reduce the ring size of the annuloplasty ring replica, and wherein the channels in adjacent articulating segments are in different locations relative to a pivot point to cause the proportional shape of the annuloplasty ring replica change for ring different sizes;

reducing the size of the adjustable ring replica to less than the maximum ring size using the actuator;

positioning the adjustable ring replica at or near a patient'"'"'s native mitral valve or tricuspid valve annulus;

increasing the ring size of the adjustable ring replica using the actuator until an outer surface contacts the valve annulus; and

determining an appropriate ring size of prosthetic annuloplasty ring for the valve annulus.

19. The method according to claim 18, wherein the shaft is malleable and couples to the annuloplasty ring replica with a swivel joint, and the step of positioning includes bending the handle and/or re-orienting the annuloplasty ring replica relative to the handle.

20. The method according to claim 18, further comprising a display on the handle configured to provide the ring size of annuloplasty ring that corresponds to incremental ring sizes of the annuloplasty ring replica, wherein the step of determining includes observing the display when the adjustable ring replica contacts the valve annulus.

21. The method according to claim 18, wherein the annuloplasty ring replica is more D-shaped for smaller ring sizes and more circular for larger ring sizes.